Associate Regulatory Affairs Manager

Associate Regulatory Affairs Manager

The Associate Regulatory Affairs Manager will support the development, review, and submission of regulatory documents for medical device and IVD products. This role will assist in managing regulatory projects, ensuring compliance with FDA, ISO 13485, and other global regulatory requirements. The Associate Manager will work cross-functionally with internal teams and external partners to support product approvals and maintain regulatory compliance throughout the product lifecycle. Assist in the preparation, review, and submission of regulatory documentation for new products, product changes, and ongoing compliance. Support the regulatory submission process for 510(k), Technical Files, and other regulatory filings. Provide regulatory guidance to cross-functional teams during product development and post-market activities under the direction of senior management. Help track and manage submission timelines, regulatory project plans, and documentation. Stay informed on changes in FDA, ISO 13485, IVDR, and other global regulations, communicating relevant updates to the team. Conduct regulatory assessments for product modifications and assist in defining appropriate submission strategies. Participate in internal and external audits, inspections, and regulatory agency communications as assigned. Contribute to the maintenance of regulatory files and submission records in accordance with internal procedures and regulations. May provide oversight and mentorship to junior staff or specialists on assigned projects.

Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field. 46 years of regulatory affairs experience in the medical device or IVD industry. Experience supporting or managing 510(k) submissions and regulatory filings. Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and international medical device regulations. Strong organizational, document management, and project coordination skills. Excellent communication, problem-solving, and cross-functional collaboration abilities. Detail-oriented with the ability to manage multiple regulatory projects and priorities. Proficient in Microsoft Office and regulatory document management systems. Ability to work independently and proactively while seeking guidance for complex issues.